TriBEL Registry: National Belgian Registry of Percutaneous Tricuspid Valve Repair Using a Transcatheter Edge-to-edge Repair Technique (TriBEL)

In this study, patients who have undergone or will undergo a transcatheter edge-to-edge repair (TEER) for tricuspid valve regurgitation (TR) will be followed up for 5 years. The goal of this prospective and retrospective, observational, non-randomized, multicenter registry is to confirm that TEER is a feasible, safe and effective treatment option for TR and to evaluate the long-term efficacy and safety of TEER.

The main endpoints are:

• Change in tricuspid regurgitation grade: number of patients with a reduction in tricuspid regurgitation score by at least one grade
• Composite of major adverse event: number of patients with composite of major adverse event (cardiovascular mortality, acute kidney injury, myocardial infarction, stroke or TIA, coronary revascularization, new onset AF or ventricular arrhythmia)

Study Overview

• Status: Not yet recruiting
• Conditions: Tricuspid Valve Regurgitation
• Intervention / Treatment: Procedure: Transcatheter edge-to-edge repair (TEER)

• Study Type: Observational
• Enrollment (Anticipated): 120

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 110 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with tricuspid valve regurgitation eligible for transcatheter edge-to-edge repair

Description

Inclusion Criteria:

• At least 18 years old
• Eligible for TEER procedure
• Informed consent signed

Exclusion Criteria:

• Unwilling to provide informed consent

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
TEER; Patients with tricuspid valve regurgitation eligible for transcatheter edge-to-edge repair (TEER)	Procedure: Transcatheter edge-to-edge repair (TEER); Minimally invasive transcatheter-based edge-to-edge repair technique for tricuspid regurgitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with a reduction in tricuspid regurgitation score by at least one grade	Number of patients with a reduction in tricuspid regurgitation score by at least one grade 30 days post-procedure	30 days
Composite of major adverse event	Number of patients with composite of major adverse event (cardiovascular mortality, acute kidney injury, myocardial infarction, stroke or TIA, coronary revascularization, new onset AF or ventricular arrhythmia)	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with a reduction in tricuspid regurgitation score by at least one grade at 6 months post-procedure	Number of patients with a reduction in tricuspid regurgitation score by at least one grade 6 months post-procedure	6 months
Number of patients with a reduction in tricuspid regurgitation score by at least one grade 1 year post-procedure	Number of patients with a reduction in tricuspid regurgitation score by at least one grade 1 year post-procedure	1 year
Number of patients with a reduction in tricuspid regurgitation score by at least one grade 2 years post-procedure	Number of patients with a reduction in tricuspid regurgitation score by at least one grade 2 years post-procedure	2 years
Number of patients with a reduction in tricuspid regurgitation score by at least one grade 3 years post-procedure	Number of patients with a reduction in tricuspid regurgitation score by at least one grade 3 years post-procedure	3 years
Number of patients with a reduction in tricuspid regurgitation score by at least one grade 4 years post-procedure	Number of patients with a reduction in tricuspid regurgitation score by at least one grade 4 years post-procedure	4 years
Number of patients with a reduction in tricuspid regurgitation score by at least one grade 5 years post-procedure	Number of patients with a reduction in tricuspid regurgitation score by at least one grade 5 years post-procedure	5 years
Composite of major adverse event at discharge	Number of patients with composite of major adverse event (cardiovascular mortality, acute kidney injury, myocardial infarction, stroke or TIA, coronary revascularization, new onset AF or ventricular arrhythmia) at discharge	5 days
Composite of major adverse event at 5 years post-procedure	Number of patients with composite of major adverse event (cardiovascular mortality, acute kidney injury, myocardial infarction, stroke or TIA, coronary revascularization, new onset AF or ventricular arrhythmia) 5 years post-procedure	5 years

Collaborators and Investigators

• Sponsor: AZ Sint-Jan AV

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2023
• Primary Completion (Anticipated): December 31, 2025
• Study Completion (Anticipated): December 31, 2029

Study Registration Dates

• First Submitted: October 7, 2022
• First Submitted That Met QC Criteria: October 10, 2022
• First Posted (Actual): October 13, 2022

Study Record Updates

• Last Update Posted (Actual): October 13, 2022
• Last Update Submitted That Met QC Criteria: October 10, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Tricuspid Valve Insufficiency
• Other Study ID Numbers: TriBEL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No